(111 days)
No
The document describes a mechanical surgical device (trocar) and its performance in bench tests. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
Explanation: The device, a surgical trocar, is used to create and maintain a port of entry during endoscopic procedures. It is an instrument for access, not a device that treats or cures a disease or condition.
No
The device is described as a surgical trocar used to create and maintain a port of entry for endoscopic procedures. Its intended use and device description focus on facilitating surgical access rather than identifying or assessing a medical condition.
No
The device description clearly states it consists of physical components like an obturator, cannula, seal, and stopcock valve, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create and maintain a port of entry" during surgical procedures. This is a surgical tool used on the patient, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details a surgical instrument (trocar) with components like an obturator, cannula, seal, and stopcock valve. These are all physical components used for surgical access.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and surgical.
N/A
Intended Use / Indications for Use
The Inno-Port Disposable Bladeless Trocars are in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry.
The Inno-Port Disposable Optical Trocars are intended for use in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Product codes
GCJ
Device Description
Inno-Port Disposable Bladeless Trocar
The Inno-Port Disposable Bladeless Trocars are available in the following configurations:
| Series | Model No. | Product Description and Specification |
|---|---|---|
| 5 mm series | DT501-7B | Disposable Trocar, 5mm, Length 70mm, Bladeless (Obturator1, Cannula1) |
| DT501-XB | Disposable Trocar, 5mm, Length 100mm, Bladeless (Obturator1, Cannula1) | |
| DT501-7L | Disposable Trocar, 5mm, Length 70mm, Bladeless (Obturator1, Cannula2) | |
| DT501-XL | Disposable Trocar, 5mm, Length 100mm, Bladeless (Obturator1, Cannula2) | |
| DT501-71 | Disposable Trocar, 5mm, Length 70mm (Cannula*1) | |
| DT501-X1 | Disposable Trocar, 5mm, Length 100mm (Cannula*1) | |
| 5-11 mm series | DTW01-XB | Disposable Trocar, 5-11mm, Length 100mm, Bladeless (Obturator1, Cannula1) |
| DTW01-SB | Disposable Trocar, 5-11mm, Length 150mm, Bladeless (Obturator1, Cannula1) | |
| DTW01-XL | Disposable Trocar, 5-11mm, Length 100mm, Bladeless (Obturator1, Cannula2) | |
| DTW01-SL | Disposable Trocar, 5-11mm, Length 150mm, Bladeless (Obturator1, Cannula2) | |
| DTW01-X1 | Disposable Trocar, 5-11mm, Length 100mm (Cannula*1) | |
| DTW01-S1 | Disposable Trocar, 5-11mm, Length 150mm (Cannula*1) | |
| 5-12 mm series | DTY01-XB | Disposable Trocar, 5-12mm, Length 100mm, Bladeless (Obturator1, Cannula1) |
| DTY01-SB | Disposable Trocar, 5-12mm, Length 150mm, Bladeless (Obturator1, Cannula1) | |
| DTY01-XL | Disposable Trocar, 5-12mm, Length 100mm, Bladeless (Obturator1, Cannula2) | |
| DTY01-SL | Disposable Trocar, 5-12mm, Length 150mm, Bladeless (Obturator1, Cannula2) | |
| DTY01-X1 | Disposable Trocar, 5-12mm, Length 100mm (Cannula*1) |
The trocar cannula contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system in the Inno-Port Disposable Bladeless Trocar is self-adjusting and accommodates instruments ranging from 5mm in diameter for trocars marked as 5mm; 5mm to 11mm in diameter for trocars marked as 11mm and 5mm to 12mm in diameter on trocars marked as 12mm. There is a stopcock valve for insufflation and rapid desufflation.
Inno-Port Disposable Optical Trocar
The Inno-Port Disposable Optical Trocar configurations:
| Series | Model No. | Product Description and Specification |
|---|---|---|
| 5 mm series | DT501-7Q | Disposable Trocar, 5mm, Length 70mm, Optical (Obturator1, Cannula1) |
| DT501-XQ | Disposable Trocar, 5mm, Length 100mm, Optical (Obturator1, Cannula1) | |
| DT501-7P | Disposable Trocar, 5mm, Length 70mm, Optical (Obturator1, Cannula2) | |
| DT501-XP | Disposable Trocar, 5mm, Length 100mm, Optical (Obturator1, Cannula2) | |
| 5-11 mm series | DTW01-XQ | Disposable Trocar, 5-11mm, Length 100mm, Optical (Obturator1, Cannula1 |
| DTW01-SQ | Disposable Trocar, 5-11mm, Length 150mm, Optical (Obturator1, Cannula1) | |
| DTW01-XP | Disposable Trocar, 5-11mm, Length 100mm, Optical (Obturator1, Cannula2) | |
| DTW01-SP | Disposable Trocar, 5-11mm, Length 150mm, Optical (Obturator1, Cannula2 | |
| 5-12 mm series | DTY01-XQ | Disposable Trocar, 5-12mm, Length 100mm, Optical (Obturator1, Cannula1) |
| DTY01-SQ | Disposable Trocar, 5-12mm, Length 150mm, Optical (Obturator1, Cannula1 | |
| DTY01-XP | Disposable Trocar, 5-12mm, Length 100mm, Optical (Obturator1, Cannula2) | |
| DTY01-SP | Disposable Trocar, 5-12mm, Length 150mm, Optical (Obturator1, Cannula2) |
The trocar cannula contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system in the Inno-Port Disposable Optical Trocar is self-adjusting and accommodates instruments ranging from in diameter for trocars marked as 5mm; 5mm to 11mm in diameter for trocars marked as 11mm and 5mm to 12mm in diameter on trocars marked as 12mm. The obturator contains a scope retention mechanism. There is a stopcock valve for insufflation and rapid desufflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench performance tests, including Stability of Trocar, Operation of Obturator, Airtightness of Cannula, and Durability of Cannula as shown below were performed on Inno-Port Disposable Bladeless Trocar/Inno-Port Disposable Optical Trocar and its predicated device respectively. For the Additional Information (AI) Request from FDA, the performance testing of proposed product and predicated product for the evaluated representative models have been conducted, and the detailed comparison table and its differences have been updated in supplements. The test results showed that both proposed devices have the similar device performance compared to the predicate device.
- Stability of Trocar
- Puncture Force Test
- Removal Force Test
- Operation of Obturator
- Insertion Force
- Withdrawal Force
- Airtightness of Cannula
- Stopcock Airtightness
- Duckbill Airtightness
- Sealing Airtightness
- Durability of Cannula
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VeraPort™ V2 Bladeless Optical Trocar (K130435, K112349), VersaOne™ Bladeless Trocar (K151548)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2023
Taiwan Surgical Corporation Ken Chen Project Director 3F., No. 12, Sec. 2 Sheng Yi Rd. Zhubei City, Hsinchu County 30261 Taiwan
Re: K223593
Trade/Device Name: Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 29, 2022 Received: December 1, 2022
Dear Ken Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
542 of the Act); 21 CFR 1000-1050.
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.03.22 15:37:30 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223593
Device Name
Inno-Port Disposable Bladeless Trocar and Inno-Port Disposable Optical Trocar
Indications for Use (Describe)
The Inno-Port Disposable Bladeless Trocars are in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry.
The Inno-Port Disposable Optical Trocars are intended for use in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary
The Assigned 510(k) Number: K223593 Date Prepared: 11/02/2022
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92
SUBMITTER: 1
| Submitter: | TAIWAN SURGICAL CORPORATION |
|---|---|
| Mailing Address: | 3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County 302, |
| Taiwan | |
| Phone Number: | +886-3-6588129 |
| Fax Number: | +886-3-6588355 |
| Contact Person: | Ken Chen |
| Title: | Project Director |
| Address: | 3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County 302 |
| Taiwan | |
| Date of submission: | 03/20/2023 |
| Email: | ra@twsc.com.tw |
| Phone Number: | +886-3-6588129 ext. 100 |
| Fax Number: | +886-3-3588355 |
| DEVICE | |
| Trade Name: | Inno-Port Disposable Bladeless Trocar and Inno-Port Disposable |
| Optical Trocar | |
| Common Name: | Surgical Trocar |
| Panel Number: | 78 Gastroenterology and Urology |
| Classification Name: | 21 CFR Part 876.1500 Endoscope and accessories |
| Classification Product Code: | GCJ |
PREDICATE DEVICE 3
Device Class:
2
VeraPort™ V2 Bladeless Optical Trocar (11&1 2mm: K130435, 5 mm: K112349)
II
VersaOne™ Bladeless Trocar (K151548)
4
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DEVICE DESCRIPTION 4
Inno-Port Disposable Bladeless Trocar
The Inno-Port Disposable Bladeless Trocars are available in the following configurations:
| Series | Model No. | Product Description and Specification |
|---|---|---|
| 5 mm | ||
| series | DT501-7B | Disposable Trocar, 5mm, Length 70mm, Bladeless (Obturator1, Cannula1) |
| DT501-XB | Disposable Trocar, 5mm, Length 100mm, Bladeless (Obturator1, Cannula1) | |
| DT501-7L | Disposable Trocar, 5mm, Length 70mm, Bladeless (Obturator1, Cannula2) | |
| DT501-XL | Disposable Trocar, 5mm, Length 100mm, Bladeless (Obturator1, Cannula2) | |
| DT501-71 | Disposable Trocar, 5mm, Length 70mm (Cannula*1) | |
| DT501-X1 | Disposable Trocar, 5mm, Length 100mm (Cannula*1) | |
| 5-11 mm | ||
| series | DTW01-XB | Disposable Trocar, 5-11mm, Length 100mm, Bladeless (Obturator1, Cannula1) |
| DTW01-SB | Disposable Trocar, 5-11mm, Length 150mm, Bladeless (Obturator1, Cannula1) | |
| DTW01-XL | Disposable Trocar, 5-11mm, Length 100mm, Bladeless (Obturator1, Cannula2) | |
| DTW01-SL | Disposable Trocar, 5-11mm, Length 150mm, Bladeless (Obturator1, Cannula2) | |
| DTW01-X1 | Disposable Trocar, 5-11mm, Length 100mm (Cannula*1) | |
| DTW01-S1 | Disposable Trocar, 5-11mm, Length 150mm (Cannula*1) | |
| 5-12 mm | ||
| series | DTY01-XB | Disposable Trocar, 5-12mm, Length 100mm, Bladeless (Obturator1, Cannula1) |
| DTY01-SB | Disposable Trocar, 5-12mm, Length 150mm, Bladeless (Obturator1, Cannula1) | |
| DTY01-XL | Disposable Trocar, 5-12mm, Length 100mm, Bladeless (Obturator1, Cannula2) | |
| DTY01-SL | Disposable Trocar, 5-12mm, Length 150mm, Bladeless (Obturator1, Cannula2) | |
| DTY01-X1 | Disposable Trocar, 5-12mm, Length 100mm (Cannula*1) |
The trocar cannula contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system in the Inno-Port Disposable Bladeless Trocar is self-adjusting and accommodates instruments ranging from 5mm in diameter for trocars marked as 5mm; 5mm to 11mm in diameter for trocars marked as 11mm and 5mm to 12mm in diameter on trocars marked as 12mm. There is a stopcock valve for insufflation and rapid desufflation.
5
Traditional 510(k), K223593
Image /page/5/Picture/1 description: The image shows the logo for TWSC, which is written in large, blue, sans-serif font. Below the logo, in a smaller, light gray font, is the phrase "Treat Patient As Family". The logo is simple and professional, and the phrase conveys a message of care and compassion.
Inno-Port Disposable Optical Trocar
| Series | Model No. | Product Description and Specification |
|---|---|---|
| 5 mm series | DT501-7Q | Disposable Trocar, 5mm, Length 70mm, Optical (Obturator1, Cannula1) |
| DT501-XQ | Disposable Trocar, 5mm, Length 100mm, Optical (Obturator1, Cannula1) | |
| DT501-7P | Disposable Trocar, 5mm, Length 70mm, Optical (Obturator1, Cannula2) | |
| DT501-XP | Disposable Trocar, 5mm, Length 100mm, Optical (Obturator1, Cannula2) | |
| 5-11 mm | ||
| series | DTW01-XQ | Disposable Trocar, 5-11mm, Length 100mm, Optical (Obturator1, Cannula1 |
| DTW01-SQ | Disposable Trocar, 5-11mm, Length 150mm, Optical (Obturator1, Cannula1) | |
| DTW01-XP | Disposable Trocar, 5-11mm, Length 100mm, Optical (Obturator1, Cannula2) | |
| DTW01-SP | Disposable Trocar, 5-11mm, Length 150mm, Optical (Obturator1, Cannula2 | |
| 5-12 mm | ||
| series | DTY01-XQ | Disposable Trocar, 5-12mm, Length 100mm, Optical (Obturator1, Cannula1) |
| DTY01-SQ | Disposable Trocar, 5-12mm, Length 150mm, Optical (Obturator1, Cannula1 | |
| DTY01-XP | Disposable Trocar, 5-12mm, Length 100mm, Optical (Obturator1, Cannula2) | |
| DTY01-SP | Disposable Trocar, 5-12mm, Length 150mm, Optical (Obturator1, Cannula2) |
The trocar cannula contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system in the Inno-Port Disposable Optical Trocar is self-adjusting and accommodates instruments ranging from in diameter for trocars marked as 5mm; 5mm to 11mm in diameter for trocars marked as 11mm and 5mm to 12mm in diameter on trocars marked as 12mm. The obturator contains a scope retention mechanism. There is a stopcock valve for insufflation and rapid desufflation.
INTENDED USE 5
Inno-Port Disposable Bladeless Trocar
The Inno-Port Disposable Bladeless Trocars are intended for use in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Inno-Port Disposable Optical Trocar
The Inno-Port Disposable Optical Trocars are intended for use in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
6
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7 MATERIAL
All patient contacting materials have been evaluated according to ISO 10993-1 and the FDA's Guidance Use of International Standard ISO 10993-1, dated Sep. 04, 2020. All biocompatibility met the acceptance criteria.
TECHNOLOGICAL CHARACTERISTICS 8
A comparison of the technological characteristics of the proposed Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar, and the predicate has been performed. The results of this comparison demonstrate that the Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar have similar technological characteristics compared to the marketed predicate device.
| Manufactures | Taiwan Surgical Corp. | Covidien |
|---|---|---|
| Product Name | Inno-Port Disposable Bladeless Trocar and | |
| Inno-Port Disposable Optical Trocar | VersaOne™ Bladeless Trocar and | |
| Versaport™ V2 Bladeless Optical Trocar | ||
| Certification | -- | K151548 |
| K112349 | ||
| K130435 | ||
| Device Class | 2 | 2 |
| Intended use | Inno-Port Disposable Bladeless Trocar: | |
| The Inno-Port Disposable Bladeless | ||
| Trocars are intended for use in a variety of | ||
| gynecologic, general thoracic and | ||
| urologic endoscopic procedures to create | ||
| and maintain a port of entry. | VersaOne™ Bladeless Trocar: | |
| The VersaOne™ Bladeless Trocars are | ||
| intended for use in a variety of | ||
| gynecologic, general, thoracic and | ||
| urologic endoscopic procedures to create | ||
| and maintain a port of entry. | ||
| Inno-Port Disposable Optical Trocar: | ||
| The Inno-Port Disposable Optical Trocars | ||
| are intended for use in a variety of | ||
| gynecologic, general thoracic and | ||
| urologic endoscopic procedures to create | ||
| and maintain a port of entry. The trocar | ||
| may be used with or without visualization | ||
| for primary and secondary insertions. | Versaport™ V2 Bladeless Optical Trocar: | |
| The Versaport™ V2 Bladeless Optical | ||
| Trocars are intended for use in a variety of | ||
| gynecologic, general, thoracic and | ||
| urologic endoscopic procedures to create | ||
| and maintain a port of entry. The trocar | ||
| may be used with or without visualization | ||
| for primary and secondary insertions. | ||
| Components | 5 mm: Obturator, Cannula with Self- | |
| Adjusting Seal and Stopcock. | 5 mm: Obturator, Cannula with Self- | |
| Adjusting Seal and Stopcock. | ||
| Manufactures | Taiwan Surgical Corp. | Covidien |
| Product Name | Inno-Port Disposable Bladeless Trocar and | |
| Inno-Port Disposable Optical Trocar | VersaOne™ Bladeless Trocar and | |
| Versaport™ V2 Bladeless Optical Trocar | ||
| 5-11/12 mm: Obturator, Cannula with | ||
| Self-Adjusting Seal, Specimen Removal | ||
| Button, and Stopcock. | 5-11/12 mm: Obturator, Cannula with | |
| Self-Adjusting Seal, Specimen Removal | ||
| Button, and Stopcock. | ||
| Specification | 5 mm | |
| Obturator: Ø 5.8 mm | ||
| Cannula: | ||
| (1) Outer diameter: Ø 8.2 mm | ||
| (2) Inside diameter: Ø 6 mm | ||
| 5-11 mm | ||
| Obturator: Ø 11.2 mm | ||
| Cannula: | ||
| (1) Outer diameter: Ø 13.8 mm | ||
| (2) Inside diameter: Ø 11.5 mm | ||
| 5-12 mm | ||
| Obturator: Ø 12.8 mm | ||
| Cannula: | ||
| (1) Outer diameter: Ø 15.35 mm | ||
| (2) Inside diameter: Ø 13 mm | 5 mm | |
| Obturator: Ø 5.85 mm | ||
| Cannula: | ||
| (1) Outer diameter: Ø 8.2 mm | ||
| (2) Inside diameter: Ø 6 mm | ||
| 5-11 mm | ||
| Obturator: Ø 11.2 mm | ||
| Cannula: | ||
| (1) Outer diameter: Ø 13.8 mm | ||
| (2) Inside diameter: Ø 11.5 mm | ||
| 5-12 mm | ||
| Obturator: Ø 12.8 mm | ||
| Cannula: | ||
| (1) Outer diameter: Ø 15.35 mm | ||
| (2) Inside diameter: Ø 13 mm | ||
| Packaging | Tyvek Pouch + Box | Tyvek Pouch + Box |
| Sterilization | Gamma | EO |
| Material and its | In accordance with | |
| ISO 10993-1 | In accordance with | |
| ISO 10993-1 | ||
| Biocompatibility | ||
| Performance | Stability of Trocar: |
- Puncture force
5 mm: 1,500 gf
5-11/12 mm: > 1,800 gf
Operation of Obturator: - Insertion Force
5 mm: 1,500 gf
5-11/12 mm: > 1,800 gf
Operation of Obturator: - Insertion Force
5 mm: